Pain in Patients With Dementia and Behavioural Disturbances

NCT01021696 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2011-08-10

No results posted yet for this study

Summary

In nursing homes (NHs) 80% of the patients have dementia, between 60%-80% exhibit behavioural disturbances (BPSD), and more than 60% have pain. Both pain and BPSD is more common in those with severe dementia. Since older persons with dementia have less communicative skills, suffer from more pain and exhibit more agitation, pain may be a contributing factor in these patients. More than 40% of patients with BPSD are treated with neuroleptics despite described side-effects. There is an urgent need to investigate the impact of individual pain management on BPSD in patients with dementia.

It was hypothesized that

* pain increase BPSD in patients with dementia
* individual pain treatment decrease BPSD in patients with dementia

Conditions

Interventions

DRUG

Paracetamol

Paracetamol Max. dose: 3g/d

DRUG

Morphine

Morphine ret. Tab. 5mgx2/d; max. dose:10mgx2/d

DRUG

Buprenorphine plaster

5ųg/h, change each 7.day; max. dose: 10ųg/h

DRUG

Pregabalin

25mgx1/d; max 300mg/d

Sponsors & Collaborators

  • The Research Council of Norway

    collaborator OTHER
  • University of Bergen

    lead OTHER

Principal Investigators

  • Rolv Terje Lie, PhD · University of Bergen, Norway

  • Bettina S. Husebo, MD, PhD · University of Bergen, Norway

  • Dag Aarsland, MD, Phd · University of Bergen, Norway

  • Clive Ballard, MD, PhD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-07-31
Completion
2010-10-31

Countries

  • Norway

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01021696 on ClinicalTrials.gov